Smart Read Eztest Steam
FDA 510(k) K112018 · Mesa Laboratories, Inc.
510(k) numberK112018
Submission
- Device name
- Smart Read Eztest Steam
- Applicant
- Mesa Laboratories, Inc.
Bozeman, MT, US - Received
- July 14, 2011
- Decision date
- January 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code FRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K201765 | SmartHDM-510 SystemFIZ · Special | 09/02/2020SE |
| K191496 | TDS Standard SolutionFKH · Traditional | 08/05/2019SE |
| K150657 | Phoenix XL Dialysate MeterFIZ · Traditional | 09/21/2015SE |
| K140589 | Sterrad Cyclesure 24 Plus Biological IndicatorFRC · Traditional | 12/03/2014SE |
| K130100 | Comined Standard SolutionFKH · Traditional | 04/18/2013SE |
| K122362 | Smart-Well IncubatorFRC · Special | 03/26/2013SE |
| K050812 | 90XL Instrumentation SystemFIZ · Special | 05/05/2005SE |
| K033330 | Conductivity/Tds Calibrator SolutionFKH · Traditional | 02/27/2004SE |
Questions and answers
When was Smart Read Eztest Steam cleared by the FDA?
Smart Read Eztest Steam (K112018) received a 510(k) decision of Substantially Equivalent on January 30, 2012, 200 days after the submission was received.
What is the product code of K112018?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.